Identity
- Trade Name
- MARK3 FDA UDI
- Generic Name
- Saliva absorbent FDA UDI
- Device Name
- Premium Bibs Lavender 3Ply 13" x 18" 500/bx. - MARK3®* FDA UDI
- Model / Reference
- 1318LA FDA UDI
- Description
- Premium Bibs Lavender 3Ply 13" x 18" 500/bx. - MARK3®* FDA UDI
Identifiers
- Catalog Number
- 1318LA FDA UDI
- Primary DI / UDI-DI
- D7961318LA1 FDA UDI
- FDA Product Code
- KHR FDA UDI
- GMDN Term
- Saliva absorbent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Saliva absorbent
Mark3 by Cargus International, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Saliva absorbent.
- Premium Plus — Premium Plus International Limited · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- ATOMO — ATOMO DENTAL, INC. · Class I
- PlastCare — PROGUARD HEALTH INC. · Class I
- Essentials by 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- Essentials by 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- Dri-Aids — YOUNG MICROBRUSH LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cargus International, Inc
Sources (1)
- FDA UDI 8d7bd040-9bcf-4b91-ad16-356c6c666b90 35 fields · synced May 31, 2026